Vista Tears Polyethylene Glycol 400 0.4% w/v recall
FDA recall D-0346-2026 · initiated Dec 31, 2025
Wizcure Pharmaa Private Limited recalled Vista Tears Polyethylene Glycol 400 0.4% w/v in Dec 2025 — an FDA Class II recall (D-0346-2026) because Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,760 cartons
Details
- Product
- Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
- Recalling company
- Wizcure Pharmaa Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Dec 31, 2025
- FDA report date
- Mar 4, 2026
Frequently asked
- Was Vista Tears Polyethylene Glycol 400 0.4% w/v recalled?
- Wizcure Pharmaa Private Limited recalled Vista Tears Polyethylene Glycol 400 0.4% w/v in Dec 2025 — an FDA Class II recall (D-0346-2026) because Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Vista Tears Polyethylene Glycol 400 0.4% w/v recalled?
- Per the FDA enforcement record, the reason for recall D-0346-2026 was: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Is a recalled Vista Tears Polyethylene Glycol 400 0.4% w/v dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Vista Tears Polyethylene Glycol 400 0.4% w/v are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — All lots. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0346-2026.